Biogen Idec and Elan Corporation announced a global Phase 3b study that is being conducted to evaluate the effectiveness of Tysabri as a treatment for secondary-progressive multiple sclerosis (SPMS).
The Ascend study is part of an ongoing commitment of both Biogen Idec and Elan to find ways to improve the well-being of patients with multiple sclerosis. Ascend (A Study to Characterize the Efficacy of Natalizumab on Disability in SPMS) is a double-blind, placebo-controlled study with SPMS patients being randomized to receive either Tysabri 300 mg or placebo intravenously every four weeks for 96 weeks. A global study, Ascend is expected to enroll approximately 850 patients in 15 countries.
Study participants will be between the ages of 18 and 58, with a diagnosis of SPMS for at least two years; an Expanded Disability Status Scale (EDSS) score between 3.0 and 6.5, MS Severity Score of four or higher; documented, confirmed evidence of disease progression, independent of clinical relapses during the one-year prior to enrollment; and naïve to Tysabri treatment.... Read More - http://www.msrc.co.uk/index.cfm/fuseact ... ageid/1768